COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio di taluni medicinali omeopatici per uso umano. (19A01014)
Estratto determina AAM/AIC n. 9/2019 del 25 gennaio 2019 1. E' rinnovata l'autorizzazione all'immissione in commercio per i seguenti medicinali omeopatici descritti in dettaglio nell'allegata tabella, composta da pagine 2, che costituisce parte integrante della presente determinazione, alle condizioni e con le specificazioni ivi indicate: Calcium Fluoratum D12 Sale Dr. Schüssler n. 1, Ferrum Phosphoricum D12 Sale Dr. Schüssler n. 3, Kalium Chloratum D6 Sale Dr. Schüssler n. 4, Kalium Phosphoricum D6 Sale Dr. Schüssler n. 5, Kalium Sulfuricum D6 Sale Dr. Schüssler n. 6, Magnesium Phosphoricum D6 Sale Dr. Schüssler n. 7, Natrium Chloratum D6 Sale Dr. Schüssler n. 8, Natrium Phosphoricum D6 Sale Dr. Schüssler n. 9, Natrium Sulfuricum D6 Sale Dr. Schüssler n. 10, Silicea D12 Sale Dr. Schüssler n. 11, Calcium Phosphoricum D6 Sale Dr. Schüssler n. 2, Calcium Sulfuricum D6 Sale Dr. Schüssler n. 12. 2. Il titolare dell'autorizzazione all'immissione in commercio e' Schwabe Pharma Italia S.r.l. con sede legale e domicilio fiscale in via Silvio Menestrina n. 1 - 39044 Egna - Neumarkt (BZ). Stampati 1. Le confezioni dei medicinali di cui all'art. 1 della presente determinazione devono essere poste in commercio con le etichette e, ove richiesto, con il foglio illustrativo, conformi ai testi allegati alla presente determinazione e che costituiscono parte integrante della stessa;
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Resta fermo l'obbligo in capo al titolare del rinnovo dell'autorizzazione all'immissione in commercio di integrare le etichette e il foglio illustrativo con le sole informazioni relative alla descrizione delle confezioni ed ai numeri di A.I.C. dei medicinali omeopatici oggetto di rinnovo con la presente determinazione;
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In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24...
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